Oral compositions

ABSTRACT

Oral compositions, such as oral gels, toothpastes and mouthwashes, containing an enzyme, a surfactant, a chelating agent, a fluoride ion source and wherein the pH of the composition is from about 4.0 to about below 6.0.

This is a continuation of application Ser. No. 998,709, filed on Dec.30, 1992, now U.S. Pat. No. 5,320,830.

TECHNICAL FIELD

The present invention relates to oral compositions containing an enzyme,a surfactant, a chelating agent and a fluoride ion source in a suitableoral carrier.

BACKGROUND OF THE INVENTION

The formation of dental plaque is the primary source of dental caries,gingival and periodontal disease and tooth loss. Dental plaque is amixed matrix of bacteria, epithelial cells, leukocytes, macrophages andother oral exudate. Bacteria comprise approximately three-quarters ofthe plaque matrix. Any given sample of dental plaque could contain asmany a 400 different varieties of microorganisms. This mix includes bothaerobic and anaerobic bacteria, fungi and protozoa. Viruses have alsobeen found in samples of dental plaque.

This matrix of organisms and oral exudate continues expanding andcoalesces with other plaque growths situated nearby. The bacteriasynthesize levans and glucans from sucrose found in the oral cavityproviding energy for the microorganisms. These glucans, levans andmicroorganisms form an adhesive skeleton for the continued proliferationof plaque.

Calculus is a yellow or white mineralized deposit of bacterial plaque.Inorganic in nature, calculus consists primarily of calcium andmagnesium phosphate and calcium carbonate. Calculus forms in layers asdoes plaque and is simply the mineralization of plaque's layeredbacteria. Calculus is formed when plaque's protein-carbohydrate matrixaccumulates calcium followed by the precipitation and mineralization ofcrystalline calcium phosphate. Once mineralized calculus is formed,another layer of bacteria adheres to the surface forming yet anotherlayer of plaque which is subsequently mineralized into calculus.

The failure to retard or stop the proliferation of plaque is detrimentalto oral health. Plaque formation leads to dental caries, gingivalinflammation, periodontal disease and ultimately tooth loss. The presentinventors recognize these problems and have developed a compositionsuitable for combating oral disease, preventing tooth loss, and leadingto general oral well-being.

The use of a variety of agents to clean the oral cavity and reduceplaque and mouth malodor has been recognized for some time. Examplesinclude: U.S. Pat. No. 3,696,191, Oct. 3, 1972 to Weeks; U.S. Pat. No.3,991,177, Nov. 9, 1976 to Vidra et al.; U.S. Pat. No. 4,058,595, Nov.15, 1977 to Colodney; U.S. Pat. No. 4,115,546, to Vidra et al.; U.S.Pat. No. 4,138,476, Feb. 6, 1979 to Simonson et al.; U.S. Pat. No.4,140,758, Feb. 20, 1979 to Vidra et al.; U.S. Pat. No. 4,154,815, May15, 1979 to Pader; U.S. Pat. No. 4,737,359, Apr. 12, 1988 to Eigen etal.; U.S. Pat. No. 4,986,981, Jan. 22, 1991 to Glace et al.; U.S. Pat.No. 4,992,420, Feb. 12, 1991 to Nesser; U.S. Pat. No. 5,000,939, Mar.19, 1991 to Dring et al.; Kokai 02/105,898, published Apr. 18, 1990 toKao Corporation; Kokai 03/128,313, published May 31, 1991 to NipponKotai Kenkyu and Kokai 03/223,209, published Oct. 2, 1991 to LionCorporation; U.S. Pat. No. 4,652,444, Mar. 24, 1987 to Maurer; U.S. Pat.No. 4,725,428, Feb. 16, 1988 to Miyahara et al.; U.S. Pat. No.4,355,022, Oct. 19, 1982 to Rabussay and PCT application WO 86/02831,published May 22, 1986 to Zetachron, Inc.

While the prior art discloses the use of various oral compositions forcombating plaque, there is still a need for additional formulationswhich provide improved performance in combating oral disease along withincreased user acceptance. The present inventors have discovered that bycombining, in a suitable carrier, a chelating agent with a calciumbinding coefficient of 10² to 10⁵, a surfactant and an enzyme, superiorcleaning results with an abatement in the formation of plaque andcalculus.

It is therefore an object of the present invention to provide an oralcare product and methods of using the same that are effective inarresting the accumulation of plaque and preventing gingivitis. It is afurther object of the present invention to provide an oral product andmethods that by reducing plaque will abate subsequent calculusformation. It is still a further object of the present invention toprovide consumers with a product that will clean the oral cavity andprovide improved methods of promoting vitality of the oral cavity.

These objectives and additional objectives will become readily apparentfrom the detailed description which follows.

SUMMARY OF THE INVENTION

The present invention relates to oral compositions which provideantiplaque, antigingivitis and anticalculus benefits with improved oralcleaning properties; comprising in one composition:

a) a safe and effective amount of a surfactant;

b) a safe and effective amount of an enzyme;

c) a safe and effective amount of a chelating agent having a calciumbinding coefficient from about 10² to about 10⁵ ;

d) a safe and effective amount of a fluoride ion source;

e) a suitable oral carrier; and

wherein the pH of the composition is from about 4.0 to about below 6.0;and wherein the composition is free of materials which complex withfluoride ions.

The present invention further relates to a method of reducing plaque,gingivitis and calculus using the above compositions.

All percentages and ratios herein are by weight unless otherwisespecified. Additionally, all measurements are made at 25° C. unlessotherwise specified.

DETAILED DESCRIPTION OF THE INVENTION

By "safe and effective amount," as used herein, means a sufficientamount to reduce plaque/gingivitis without harming the tissues andstructures of the oral cavity.

By the term "suitable oral carrier," as used herein, means a suitablevehicle which can be used to apply the present compositions to the oralcavity in a safe and effective manner.

The compositions of this invention employ a safe and effective amount ofa surfactant, an enzyme, a chelating agent having a calcuim bindingcoefficient of about 10² to about 10⁵, a fluoride ion source safe foruse in the oral cavity and wherein the composition is free of materialswhich complex with fluoride ions contained in a suitable carrier. At thetime of usage an amount of the composition is applied to the oralcavity. This amount of the composition is then preferably allowed toremain in contact with the tissues of the oral cavity for from about 15seconds to about 12 hours. Alternatively, the composition could be lefton indefinitely, or more practically until the composition is removed bya mechanical process; e.g., chewing foods or drinking liquids. Thisprolonged contact with the tissues of the oral cavity allows thecomposition to work for a period longer than conventional oralcompositions that are applied and then brushed or rinsed away.

The pH of the present herein described compositions range from about 4.0to about below 6.0, with the preferred pH being from about 4.5 to aboutbelow 6.0 and the most preferred pH being from about 5.0 to about below6.0.

The essential as well as optional components of the compositions of thepresent invention are described in the following paragraphs.

ESSENTIAL INGREDIENTS Surfactants:

One of the essential agents required by the present invention is asurfactant or a mixture of compatible surfactants. Suitable surfactantsare those which are reasonably stable throughout a wide pH range, i.e.,non-soap anionic, cationic, nonionic or zwitterionic surfactants.

Suitable surfactants are described more fully in U.S. Pat. No.3,959,458, May 25, 1976 to Agricola et al.; U.S. Pat. No. 3,937,807,Feb. 10, 1976 to Haefele; and U.S. Pat. No. 4,051,234, Sep. 27, 1988 toGieske et al. These patents are incorporated herein by reference.

Preferred anionic surfactants useful herein include the water-solublesalts of alkyl sulfates having from 10 to 18 carbon atoms in the alkylradical and the water-soluble salts of sulfonated monoglycerides offatty acids having from 10 to 18 carbon atoms. Sodium lauryl sulfate,sodium lauroyl sarcosinate and sodium coconut monoglyceride sulfonatesare examples of anionic surfactants of this type. Mixtures of anionicsurfactants can also be utilized.

Preferred cationic surfactants useful in the present invention can bebroadly defined as derivatives of aliphatic quaternary ammoniumcompounds having one long alkyl chain containing from about 8 to 18carbon atoms such as lauryl trimethylammonium chloride; cetyl pyridiniumchloride; cetyl trimethylammonium bromide;di-isobutylphenoxyethyldimethylbenzylammonium chloride; coconutalkyltrimethylammonium nitrite; cetyl pyridinium fluoride; etc.

Preferred compounds are the quaternary ammonium fluorides described inU.S. Pat. No. 3,535,421, Oct. 20, 1970, to Briner et al., hereinincorporated by reference, where said quaternary ammonium fluorides havedetergent properties. Certain cationic surfactants can also act asgermicides in the compositions disclosed herein. Cationic surfactantssuch as chlorhexadine, although suitable for use in the currentinvention, are not preferred due to their capacity to stain the oralcavity's hard tissues. Persons skilled in the art are aware of thispossibility and should incorporate a cationic surfactant only with thislimitation in mind.

Preferred nonionic surfactants that can be used in the compositions ofthe present invention can be broadly defined as compounds produced bythe condensation of alkylene oxide groups (hydrophilic in nature) withan organic hydrophobic compound which may be aliphatic or alkylaromaticin nature. Examples of suitable nonionic surfactants include thePluronics, polyethylene oxide condensates of alkyl phenols, productsderived from the condensation of ethylene oxide with the reactionproduct of propylene oxide and ethylene diamine, ethylene oxidecondensates of aliphatic alcohols, long chain tertiary amine oxides,long chain tertiary phosphine oxides, long chain dialkyl sulfoxides andmixtures of such materials.

Preferred zwitterionic synthetic surfactants useful in the presentinvention can be broadly described as derivatives of aliphaticquaternary ammonium, phosphomium, and sulfonium compounds, in which thealiphatic radicals can be straight chain or branched, and wherein one ofthe aliphatic substituents contains from about 8 to 18 carbon atoms andone contains an anionic water-solubilizing group, e.g., carboxy,sulfonate, sulfate, phosphate or phosphonate.

The surfactant or mixtures of compatible surfactants can be present inthe compositions of the present invention from about 0.1% to about 5.0%,preferably from about 0.3% to about 3.0% and most preferably from about0.5% to about 2.0% by weight of the total composition. The surfactantsbest suited for inclusion into the present composition are: sodium alkylsulfate, sodium lauroyl sarcosinate, cocoamidopropyl betaine andpolysorbate 20, with sodium lauroyl sarcosinate being preferred and acombination of sodium lauroyl sarcosinate and cocoamidopropyl betainebeing most preferred.

Chelating agents:

Chelating agents are able to complex calcium found in the cell walls ofthe bacteria. Binding of this calcium weakens the bacterial cell walland augments bacterial lysis. However, it is possible to use a chelatingagent which has an affinity for calcium that is too high.

Another group of agents suitable for use as chelating agents in thepresent invention are the soluble pyrophosphates. The pyrophosphatesalts used in the present compositions can be any of the alkali metalpyrophosphate salts. Specific salts include tetra alkali metalpyrophosphate, dialkali metal diacid pyrophosphate, trialkali metalmonoacid pyrophosphate and mixtures thereof, wherein the alkali metalsare preferably sodium or potassium. The salts are useful in both theirhydrated and unhydrated forms. An effective amount of pyrophosphate saltuseful in the present composition is generally enough to provide atleast 1.0% pyrophosphate ions, preferably from about 1.5% to about 6%,more preferably from about 3.5% to about 6% of such ions. It is to beappreciated that the level of pyrophosphate ions is that capable ofbeing provided to the composition (i.e., the theoretical amount at anappropriate pH) and that pyrophosphate forms other than P₂ O₇ --4 (e.g.,(HP₂ O₇ --3)) may be present when a final product pH is established.

The pyrophosphate salts are described in more detail in Kirk & Othmer,Encyclopedia of Chemical Technology, Second Edition, Volume 15,Interscience Publishers (1968), incorporated herein by reference.

Still another possible group of chelating agents suitable for use in thepresent invention are the anionic polymeric polycarboxylates. Suchmaterials are well known in the art, being employed in the form of theirfree acids or partially or preferably fully neutralized water solublealkali metal (e.g. potassium and preferably sodium) or ammonium salts.Preferred are 1:4 to 4:1 copolymers of maleic anhydride or acid withanother polymerizable ethylenically unsaturated monomer, preferablymethyl vinyl ether (methoxyethylene) having a molecular weight (M.W.) ofabout 30,000 to about 1,000,000. These copolymers are available forexample as Gantrez AN 139(M.W. 500,000), AN 119 (M.W. 250,000) andpreferably S-97 Pharmaceutical Grade (M.W. 70,000), of GAF ChemicalsCorporation.

Other operative polymeric polycarboxylates include those such as the 1:1copolymers of maleic anhydride with ethyl acrylate, hydroxyethylmethacrylate, N-vinyl-2-pyrollidone, or ethylene, the latter beingavailable for example as Monsanto EMA No. 1103, M.W. 10,000 and EMAGrade 61, and 1:1 copolymers of acrylic acid with methyl or hydroxyethylmethacrylate, methyl or ethyl acrylate, isobutyl vinyl ether orN-vinyl-2-pyrrolidone.

Additional operative polymeric polycarboxylates are disclosed in U.S.Pat. No. 4,138,477, Feb. 6, 1979 to Gaffar and U.S. Pat. No. 4,183,914,Jan. 15, 1980 to Gaffar et al. both patents are incorporated herein byreference, and include copolymers of maleic anhydride with styrene,isobutylene or ethyl vinyl ether, poly-acrylic, polyitaconic andpolymaleic acids, and sulfoacrylic oligomers of M.W. as low as 1,000available as Uniroyal ND-2.

Suitable generally, are polymerized olefinically or ethylenicallyunsaturated carboxylic acids containing an activated carbon-to-carbonolefinic double bond and at least one carboxyl group, that is, an acidcontaining an olefinic double bond which readily functions inpolymerization because of its presence in the monomer molecule either inthe alpha-beta position with respect to a carboxyl group or as part of aterminal methylene grouping. Illustrative of such acids are acrylic,methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxypropionic, sorbic, alpha-chlorsorbic, cinnamic, beta-styrylacrylic,muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic,alpha-phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic,umbellic, fumaric, maleic acids and anhydrides. Other different olefinicmonomers copolymerizable with such carboxylic monomers includevinylacetate, vinyl chloride, dimethyl maleate and the like. Copolymerscontain sufficient carboxylic salt groups for water-solubility.

The linear anionic polymeric polycarboxylate component is mainly ahydrocarbon with optional halogen and oxygen containing substituents andlinkages as present in for example ester, ether and OH groups, and whenpresent is generally employed in the instant compositions in approximateweight amounts of about 0.05 to about 3%, preferably from about 0.05 toabout 2%, more preferably from about 0.1 to about 2%.

A further class of polymeric agents includes a composition containinghomopolymers of substituted acrylamides and/or homopolymers ofunsaturated sulfonic acids and salts thereof, in particular wherepolymers are based on unsaturated sulfonic acids selected fromacrylamidoalykane sulfonic acids such as 2-acrylamide 2 methylpropanesulfonic acid having a molecular weight from 1,000-2,000,000, describedin U.S. Pat. No. 4,842,847, Jun. 27, 1989 to Zahid, incorporated hereinby reference.

Another useful class of polymeric agents includes polyamino acids,particularly those containing proportions of anionic surface-activeamino acids such as aspattic acid, glutamic acid and phosphoserine, asdisclosed in U.S. Pat. No. 4,866,161 Sep. 12, 1989 to Sikes et al.,incorporated herein by reference.

All the above chelating agents are suitable for inclusion into thepresent invention, however, the polymeric polycarboxylates are preferredand a combination of citric acid and an alkali metal citrate salt ismost preferred, with sodium citrate being the salt most preferred.

Enzymes:

Another of the essential components of the current invention is anenzyme or a mixture of several compatible enzymes. Enzymes arebiological catalysts of chemical reactions in living systems. Enzymescombine with the substrates on which they act forming an intermediateenzyme-substrate complex. This complex is then converted to a reactionproduct and a liberated enzyme which continues its specific enzymaticfunction.

Enzymes provide several benefits when used for cleansing of the oralcavity. Proteases break down salivary proteins which are adsorbed ontothe tooth surface and form the pellicle; the first layer of resultingplaque. Proteases along with lipases destroy bacteria by lysing proteinsand lipids which form the structural component of bacterial cell wallsand membranes. Dextranases break down the organic skeletal structureproduced by bacteria that forms a matrix for bacterial adhesion.Proteases and amylases, not only prevent plaque formation, but alsoprevent the development of calculus by breaking-up thecarbohydrate-protein complex that binds calcium, preventingmineralization.

Useful enzymes include any of the commercially available proteases,glucanohydrolases, endoglycosidases, amylases, mutanases, lipases andmucinases or compatible mixtures thereof. Preferred are the proteases,dextranases, endoglycosidases and mutanases, most preferred beingpapain, endoglycosidase or a mixture of dextranase and mutanase.Additional enzymes suitable for use in the present invention aredisclosed in U.S. Pat. No. 5,000,939 to Dring et al., Mar. 19, 1991,U.S. Pat. No. 4,992,420 to Neeser, Feb. 12, 1991, U.S. Pat. No.4,355,022 to Rabussay, Oct. 19, 1982, U.S. Pat. No. 4,154,815 to Pader,May 15, 1979, U.S. Pat. No. 4,058,595 to Colodney, Nov. 15, 1977, U.S.Pat. No. 3,991,177 to Virda et al., Nov. 9, 1976 and U.S. Pat. No.3,696,191 to Weeks, Oct. 3, 1972 all incorporated herein by reference.An enzyme of a mixture of several compatible enzymes in the currentinvention constitutes from about 0.002% to about 2.0%, preferably fromabout 0.05% to about 1.5% and most preferably from about 0.1% to about0.5%.

Fluoride ion source:

A fluoride ion source is an essential ingredient of the presentinvention. Fluoride ion sources are added to the present inventions at alevel of from about 0.01% to 3.0%, preferably from about 0.03% to 1.0%,by weight of the composition. Fluoride ions combine with dental enameland thereby reduce enamel solubility in acid. Application of fluorideions to dental enamel serves to protect teeth against decay.

A wide variety of fluoride ion-yielding materials can be employed assources of soluble fluoride in the present compositions. Examples ofsuitable fluoride ion-yielding materials are found in U.S. Pat. No.3,535,421, Oct. 20, 1970 to Briner et al.; U.S. Pat. No. 4,885,155, Dec.5, 1989 to Parran, Jr. et al. and U.S. Pat. No. 3,678,154, Jul. 18, 1972to Widder et al., both being incorporated herein by reference.Representative fluoride ion sources include: Stannous fluoride, sodiumfluoride, potassium fluoride, sodium monofluorophosphate and manyothers. Stannous fluoride and sodium fluoride are particularlypreferred, as well as mixtures thereof.

OPTIONAL INGREDIENTS

In addition to the above described essential components, the embodimentsof this invention can contain a variety of optional dentifriceingredients some of which are described below. Optional ingredientsinclude, for example, but are not limited to, adhesives, sudsing agents,flavoring agents, sweetening agents, additional antiplaque agents,abrasives, and coloring agents. These and other optional components arefurther described in U.S. Pat. No. 5,004,597, Apr. 2, 1991 to Majeti;U.S. Pat. No. 3,959,458, May 25, 1976 to Agricola et al. and U.S. Pat.No. 3,937,807, Feb. 10, 1976 to Haefele, all being incorporated hereinby reference.

Abrasives:

Abrasive polishing materials might also be incorporated into dentifricecompositions of the present invention. Suitable abrasives can be anymaterial which does not excessively abrade dentin and does not providecalcium ions that may precipitate with, for example, the fluoride ionsprovided by any included fluoride ion source or that might complex withthe composition's chelating agent. Suitable abrasives include, forexample, silicas including gels and precipitates, insoluble sodiumpolymetaphosphate, beta-phase calcium pyrophosphate, and resinousabrasive materials such as particulate condensation product of urea andformaldehyde, and others such as compounds disclosed in U.S. Pat. No.3,070,510, Dec. 25, 1962, to Cooley et al. incorporated herein byreference. Combinations of abrasives may also be used. Abrasives such ascalcium carbonate, calcium phosphate and regular calcium pyrophosphateare not preferred for use in the present composition since they containcalcium ions that have the ability to complex with either an includedfluoride ion source or the invention's chelating agent.

Silica dental abrasives, of various types, can contribute thecharacteristic benefits of superior dental cleaning and polishingwithout excessively abrading tooth enamel or dentin. Silica abrasivesmaterials are also exceptionally compatible with the essential andoptional components of the present invention. For these reasons silicaabrasives are preferred for use within the present invention.

The silica abrasive polishing materials useful herein, as well as theother abrasives, generally have an average particle size ranging betweenabout 0.1 and 30 microns, preferably from between 5 and 15 microns. Theincluded silica abrasives can be from precipitated silica or silicagels, such as the silica xerogels described in U.S. Pat. No. 3,538,230,Mar. 2, 1970 to Pader et al. and U.S. Pat. No. 3,862,307, Jun. 21, 1975to Digiulio, both incorporated herein by reference. Preferred silicaxerogels are marketed under the trade name "Syloid" by the W. R. Grace &Co., Davison Chemical Division. The preferred precipitated silicamaterials include those marketed by the J. M. Huber Corp. under thetrade name, "Zeodent"; especially the silica carrying the designation"Zeodent 119". These silica abrasives are described in U.S. Pat. No.4,340,583, Jul. 29, 1982 to Wason, incorporated herein by reference.

The abrasives in the compositions described herein are incorporated at alevel from about 6% to about 70%, preferably from about 15% to about 30%when the oral composition is a dentifrice toothpaste.

Flavoring agents:

Flavoring agents can also be added to oral dentifrice compositions ofthe present invention. Appropriate flavoring agents include oil ofwintergreen, oil of peppermint, oil of spearmint, oil of sassafras, oilof clove and any other of the many known flavoring agents orcombinations thereof.

Sweeting agents:

Possible sweeting agents which may be included for use in the presentinvention include: aspartame, acesulfame, saccharin, dextrose, levuloseand sodium cyclamate. Flavoring and sweeting agents are customarily usedin oral dentifrice compositions at levels from about 0.005% to about 2%by weight.

Water:

Water may also be present in the oral compositions of this invention.Water, employed in the preparation of commercial oral compositionsshould, preferably, be deionized and free of organic impurities. Watercommonly comprises from about 10% to 50%, preferably from about 20% toabout 40% and most preferably from about 10% to about 15% by weight ofthe oral compositions described herein. This amount of water includesthe free water which is added plus that amount which is introduced withother materials such as with sorbitol or any components of theinvention.

Thickening agents:

In preparing oral compositions, it is sometimes necessary to add somethickening material to provide a desirable consistency. Preferredthickening agents are carboxyvinyl polymers, carrageenan, hydroxyethylcellulose and water soluble salts of cellulose ethers such as sodiumcarboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose.Natural gums such as karaya, gum arabic, and gum tragacanth can also beincorporated. Colloidal magnesium aluminum silicate or finely dividedsilica can be used as component of the thickening composition to furtherimprove the composition's texture. Thickening agents in an amount from0.5% to 5.0% by weight of the total composition can be used.

Humectants:

Within oral compositions, it is also desirable to incorporate ahumectant to prevent the composition from hardening upon exposure toair. Certain humectants can also impart desirable sweetness or flavor todentifrice compositions. The humectant, on a pure humectant basis,generally comprises from about 15% to about 70%, preferably from about30% to about 65%, by weight of the dentifrice composition.

Suitable humectants include edible polyhydric alcohols such asglycerine, sorbitol, xylitol, propylene glycol as well as other polyolsand mixtures of these humectants. Mixtures of glycerine and sorbitol areespecially preferred as the humectant component of the toothpastecompositions herein.

Adhesives:

In the compositions of the present invention, an adhesive is alsodesirable helping the active ingredients to adhere to the tissues of theoral cavity. Suitable adhesives include both polymers with limited watersolubility as well as polymers lacking water solubility. These polymersdeposit a thin film on both the oral cavity's soft and hard tissues whensaliva combines with the instant composition. Suitable limited watersolubility adhesives include: hydroxy ethyl or propyl cellulose.Adhesives lacking water solubility include: ethyl cellulose, polyoxresins and silicones. Adhesives lacking water solubility areincorporated into the instant invention by using a small amount of ethylalcohol or another alcohol safe for use in the oral cavity and the humanbody.

Another possible adhesive suitable for use in the instant composition ispolyvinylpyrrolidone ("PVP") with a molecular weight of about 50,000 toabout 300,000, a suitable PVP is available from GAF ChemicalsCorporation.

Still another possible adhesive suitable for use in the instantcomposition is a combination of Gantrez and the semisynthetic,water-soluble polymer carboxymethyl cellulose ("CMC"). Preferred is amixture of 2:1 to 1:1 (Gantrez to CMC). Suitable for use in thecombination is Gantrez with a M.W. of about 30,000 to about 1,000,000available from GAF Chemicals Corporation and CMC with a M.W. of about90,000 to about 700,000 available from Aqualon Company.

METHOD OF MANUFACTURE

The compositions of the present invention can be made using methodswhich are common in the oral product area.

COMPOSITION USE

The present invention in its method aspect involves applying to the oralcavity a safe and effective amount of the compositions described herein.These amounts (e.g. from about 0.3 to about 2 gm), if it is a toothpasteor toothgel is kept in the mouth from about 15 seconds to about 12hours.

The following examples further describe and demonstrate preferredembodiments within the scope of the present invention. The examples aregiven solely for illustration and are not to be construed as limitationsof this invention as many variations are possible without departing fromthe spirit and scope thereof.

Example I

A dentifrice composition of the present invention contains the followingcomponents as described below.

    ______________________________________                                        Sorbitol            49.127                                                    Carbopol 956*       0.250                                                     Xantham gum         0.425                                                     Titanium dioxide    0.525                                                     Silica              20.000                                                    Citric acid         0.900                                                     Sodium citrate      5.000                                                     Sodium lauroyl sarcosinate                                                                        4.000                                                     (30% solution)                                                                Endoglycosidase     6.250                                                     (3.2% solution)                                                               Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              0.900                                                     Water               q.s.                                                      Sodium Saccharin    0.130                                                     ______________________________________                                         *Carboxyvinyl polymer supplied by B.F. Goodrich Company as Carbomer 956. 

PROCEDURE FOR MAKING DENTRIFICE.

Dentifrices of the instant composition are manufactured by setting thejacket temperature of a mixing tank to about 150° to about 165° degreesFahrenheit. The humectants and water are added to the mixing tank andagitation is started. When the temperature reaches approximately 120°add fluoride, sweetening agents, buffering agents, coloring agents andtitanium dioxide. Premix thickening agents into the abrasive and addthis mixture to the mixing tank with high agitation. Add surfactant tothe combination and continue mixing. Cool tank to 120°, add flavoringagents and continue mixing for approximately 5 minutes. Further cool themixing tank to about 95° to about 100° and add the enzyme, mix for anadditional 20 minutes. The pH of the composition will be between about4.0 to about below 6.0.

Examples II-VIII are further examples of dentifrices of the presentinvention.

Example II

    ______________________________________                                        Sorbitol            54.477                                                    Carbopol 956        0.250                                                     Xantham gum         0.425                                                     Titanium dioxide    0.525                                                     Silica              20.000                                                    Citric acid         0.900                                                     Sodium citrate      5.000                                                     Sodium lauroyl sarcosinate                                                                        2.667                                                     (30% solution)                                                                Cocoamidopropyl betaine                                                                           2.667                                                     (30% solution)                                                                Papain              0.500                                                     Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              0.900                                                     Water               q.s.                                                      Sodium Saccharin    0.130                                                     ______________________________________                                    

Example III

    ______________________________________                                        Sorbitol            25.672                                                    Glycerin            20.000                                                    Carbopol 956        0.250                                                     Xantham gum         0.425                                                     Titanium dioxide    0.525                                                     Silica              20.000                                                    Citric acid         0.800                                                     Sodium citrate      4.200                                                     Sodium lauroyl sarcosinate                                                                        4.000                                                     (30% solution)                                                                Cocoamidopropyl betaine                                                                           1.333                                                     (30% solution)                                                                Endoglycosidase     9.375                                                     (3.2% solution)                                                               Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              1.000                                                     Water               q.s.                                                      Sodium Saccharin    0.130                                                     ______________________________________                                    

Example IV

    ______________________________________                                        Sorbitol            32.379                                                    Glycerin            15.000                                                    Carboxymethyl cellulose                                                                           0.800                                                     Titanium dioxide    0.525                                                     Silica              25.000                                                    Citric acid         0.800                                                     Sodium citrate      4.200                                                     Sodium alkyl sulfate                                                                              2.000                                                     (30% solution)                                                                Sodium lauroyl sarcosinate                                                                        2.000                                                     (30% solution)                                                                Cocoamidopropyl betaine                                                                           0.333                                                     (30% solution)                                                                Papain              0.400                                                     Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              1.000                                                     Water               q.s.                                                      Sodium Saccharin    0.270                                                     ______________________________________                                    

Example V

    ______________________________________                                        Sorbitol            36.757                                                    Glycerin            10.000                                                    Carbopol 956        0.250                                                     Xantham gum         0.425                                                     Titanium oxide      0.525                                                     Silica              30.000                                                    Citric acid         0.600                                                     Sodium citrate      3.000                                                     Sodium lauroyl sarcosinate                                                                        3.333                                                     (30% solution)                                                                Cocoamidopropyl betaine                                                                           1.667                                                     (30% solution)                                                                Papain              0.500                                                     Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              0.900                                                     Water               q.s.                                                      Sodium Saccharin    0.250                                                     ______________________________________                                    

Example VI

    ______________________________________                                        Sorbitol            48.127                                                    Carbopol 956        0.250                                                     Xantham gum         0.425                                                     Titanium oxide      0.525                                                     Silica              20.000                                                    Citric acid         0.900                                                     Sodium citrate      5.000                                                     Sodium lauroyl sarcosinate                                                                        4.000                                                     (30% solution)                                                                Endoglycosidase     6.250                                                     (3.2% solution)                                                               Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              0.900                                                     Water               q.s.                                                      Sodium Saccharin    0.130                                                     Mineral oil         1.000                                                     ______________________________________                                    

Example VII

    ______________________________________                                        Sorbitol            54.377                                                    Carbopol 956        0.250                                                     Xantham gum         0.425                                                     Titanium oxide      0.525                                                     Silica              20.000                                                    Citric acid         1.500                                                     Sodium citrate      4.500                                                     Sodium lauroyl sarcosinate                                                                        2.667                                                     (30% solution)                                                                Cocoamidopropyl betaine                                                                           2.667                                                     (30% solution)                                                                Papain              0.500                                                     Sodium fluoride     0.243                                                     FD&C blue #1        0.050                                                     Flavor              0.900                                                     Water               q.s.                                                      Sodium Saccharin    0.130                                                     ______________________________________                                    

Example VIII

    ______________________________________                                        Sorbitol            61.814                                                    Carbopol 956        0.314                                                     Xantham gum         0.534                                                     Citric acid         1.132                                                     Sodium citrate      6.291                                                     Sodium lauroyl sarcosinate                                                                        5.033                                                     (30% solution)                                                                Endoglycosidase     7.864                                                     (3.2% solution)                                                               Sodium fluoride     0.305                                                     FD&C blue #1        0.062                                                     Flavor              1.132                                                     Water               q.s.                                                      Sodium Saccharin    2.768                                                     ______________________________________                                    

Example IX

    ______________________________________                                        Sorbitol            68.546                                                    Carbopol 956        0.314                                                     Xantham gum         0.534                                                     Citric acid         1.132                                                     Sodium citrate      6.291                                                     Sodium lauroyl sarcosinate                                                                        3.355                                                     (30% solution)                                                                Cocoamidoprophyl betaine                                                                          3.355                                                     (30% solution)                                                                Papain              0.629                                                     Sodium fluoride     0.305                                                     FD&C blue #1        0.062                                                     Flavor              1.132                                                     Water               q.s.                                                      Sodium Saccharin    0.163                                                     ______________________________________                                    

Example X

    ______________________________________                                        Sorbitol            32.301                                                    Glycerin            25.165                                                    Carbopol 956        0.314                                                     Xantham gum         0.534                                                     Citric acid         1.006                                                     Sodium citrate      5.284                                                     Sldium lauroyl sarcosinate                                                    (30% solution)      5.033                                                     Cocoamidopropyl betaine                                                       (30% solution)      1.677                                                     Endoglycosidase                                                               (3.2% solution)     11.179                                                    Sodium fluoride     0.305                                                     FD&C blue #1        0.062                                                     Flavor              1.258                                                     Water               q.s.                                                      Sodium Saccharin    0.163                                                     ______________________________________                                    

Example XI

    ______________________________________                                        Sorbitol            68.420                                                    Carbopol 956        0.314                                                     Xantham gum         0.534                                                     Citric acid         1.887                                                     Sodium citrate      5.662                                                     Sodium lauroyl sarcosinate                                                    (30% solution)      3.355                                                     Cocoamidopropyl betaine                                                       (30% solution)      3.355                                                     Papain              0.629                                                     Sodium fluoride     0.305                                                     FD&C blue #1        0.063                                                     Flavor              1.132                                                     Water               q.s.                                                      Sodium Saccharin    0.163                                                     ______________________________________                                    

In the above examples, substantially similar results are obtained whenthe surfactant(s), enzyme(s), chelating agent(s) and combinationsthereof are substituted with other similar components herein disclosedand described.

What is claimed is:
 1. An oral composition providing improved oralcleansing properties, comprising:a) a safe and effective amount of asurfactant; b) a safe and effective amount of an enzyme; c) a safe andeffective amount of a chelating agent having a calcium bindingcoefficient of from about 10² to about 10⁵ wherein the the luring agentis selected from the group consisting of citric acid, alkali metalcitrate, polymeric polycarboxylates, soluble pyrophosphates and mixturesthereof; d) a safe and effective amount of a fluoride ion source; and e)a suitable oral carrier;wherein the pH of the composition is from about4.0 to about below 6.0, the composition is free of materials whichcomplex with fluoride ions and wherein said composition is free of thecombination of citric acid and the alkyl metal citrate.
 2. An oralcomposition according to claim 1 wherein the surfactant is selected fromthe group consisting of sodium lauroyl sarcosinate, sodium alkylsulfate, cocoamidopropyl betaine, polysorbate 20 and mixtures thereof.3. An oral composition according to claim 2 wherein the enzyme isselected from the group consisting of endoglycosidase, papain,dextranase, mutanase and mixtures thereof.
 4. An oral compositionaccording to claim 3 wherein the fluoride ion source is selected fromthe group consisting of sodium fluoride, stannous fluoride, sodiummonofluorophosphate, potassium fluoride and mixtures thereof.
 5. An oralcomposition according to claim 4 which further comprises from about 15%to about 70% of a humectant selected from the group consisting ofglycerin and sorbitol and mixtures thereof.
 6. An oral compositionaccording to claim 5 wherein the surfactant is present at a level fromabout 0.1% to about 5.0%.
 7. An oral composition according to claim 6wherein the enzyme is present at a level from about 0.002% to about2.0%.
 8. An oral composition according to claim 7 which furthercomprises an abrasive.
 9. A method of reducing and preventing plaque andgingivitis, comprising the application of a safe and effective amount ofa composition according to claim 1, to the teeth and other oralsurfaces.
 10. A method of reducing and preventing plaque and gingivitis,comprising the application of a safe and effective amount of acomposition according to claim 5, to the teeth and other oral surfaces.11. A method of reducing and preventing plaque and gingivitis,comprising the application of a safe and effective amount of acomposition according to claim 7, to the teeth and other oral surfaces.12. A method of reducing and preventing plaque and gingivitis,comprising the application of a safe and effective amount of acomposition according to claim 8 to the teeth and other oral surfaces.13. A method of reducing and preventing plaque and gingivitis,comprising the application of a safe and effective amount of acomposition according to claim 1 to the teeth and other oral surfaceswherein the composition is allowed to remain on the teeth and other oralsurfaces for from about 15 seconds to about 12 hours.
 14. A method ofreducing and preventing plaque and gingivitis, comprising theapplication of a safe and effective amount of a composition according toclaim 5 to the teeth and other oral surfaces wherein the composition isallowed to remain on the teeth and other oral surfaces for from about 15seconds to about 12 hours.
 15. A method of reducing and preventingplaque and gingivitis, comprising the application of a safe andeffective amount of a composition according to claim 8 to the teeth andother oral surfaces wherein the composition is allowed to remain on theteeth and other oral surfaces for from about 15 seconds to about 12hours.